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FDA 510(k)

SPECTRUM(TENTATIVE)

K-Number: K852078 · 1985-06-07

ApplicantParke-Davis Co.
Decision Date1985-06-07
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SPECTRUM(TENTATIVE) is the device name listed in this FDA 510(k) record. The listed applicant is Parke-Davis Co.. It received FDA 510(k) clearance on 1985-06-07 under 510(k) number K852078. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTRUM(TENTATIVE)?

SPECTRUM(TENTATIVE) is a medical device that received FDA 510(k) clearance on 1985-06-07. The listed applicant is Parke-Davis Co.. The 510(k) number is K852078.

When did SPECTRUM(TENTATIVE) receive FDA 510(k) clearance?

SPECTRUM(TENTATIVE) received FDA 510(k) clearance on 1985-06-07, under 510(k) number K852078.

Who is the listed applicant for SPECTRUM(TENTATIVE)?

The FDA 510(k) record lists Parke-Davis Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPECTRUM(TENTATIVE)?

The FDA product code for SPECTRUM(TENTATIVE) is FOZ.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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